Abstract:
OBJECTIVE To simulate the full process application of digital intelligent clinical research model in a real clinical research setting and compare its performance in terms of research cost and efficiency with the traditional clinical research model.
METHODS In a real-world observational clinical research project in the Department of Cardiology, the digital intelligent clinical research model was used to simulate and verify the entire process, including patient recruitment, data entry, trial monitoring, and project inspection. Key indicators such as working hours and data entry accuracy were statistically analyzed, and the results were retrospectively compared with those under the traditional research model.
RESULTS A total of 52 patients were enrolled in the clinical research project. Under the digital intelligent clinical research model, 4 240 potential patients were screened, with an expected enrollment of 66 people and a screening total time of 6.00 h. During the data entry phase, clinical coordinators’ working hours were reduced(digital intelligent clinical research model: 107.21 h vs traditional clinical research model: 141.90 h) and accuracy improved(digital intelligent clinical research model: 97.23% vs traditional clinical research model: 85.54%). In the data monitoring phase, total monitoring hours for clinical monitors were reduced(digital intelligent clinical research model: 72.00 h vs traditional clinical research model: 169.50 h), and the number of queries decreased(digital intelligent clinical research model: 1156 queries vs traditional clinical research model: 1541 queries).
CONCLUSION In this study, the digitalized clinical research model significantly enhance patient recruitment efficiency and data entry accuracy through the use of artificial intelligence, while also reducing operational time and costs. The digitalized model demonstrate clear advantages in improving the efficiency and quality of clinical trials. Future research needs to further optimize the technology and expand its application scope to fully leverage its potential.
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